Anti-PCSK9 Antibody Tafolecimab and Anti-PD-1 Antibody Sintilimab Combined With Neoadjuvant Chemoradiotherapy for pMMR/ MSS Locally Advanced Rectal Cancer : A Prospective, Multicenter, Randomized, Open-Label, Parallel-Controlled Trial

This is a randomized, controlled clinical trial based on prior exploratory findings, designed to evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with tafolecimab(an anti-PCSK9 inhibitor) and sintilimab (an anti-PD-1 inhibitor) versus neoadjuvant chemoradiotherapy combined with sintilimab alone in patients with pMMR/MSS locally advanced rectal cancer. The primary endpoint is the complete response (CR) rate, including the pathological complete response (pCR) rate in patients who undergo surgery after neoadjuvant therapy, and the clinical complete response (cCR) rate in patients managed with a watch-and-wait strategy. Secondary endpoints include major pathological response (MPR) rate, objective response rate (ORR), downstaging rate, R0 resection rate, tumor regression grade, sphincter preservation rate, disease-free survival (DFS), overall survival (OS), and safety.

NCT Number	NCT07686796
Lead Sponsor	Guangdong Provincial People's Hospital Collaborators: Beijing Friendship Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Fudan University, Sixth Affiliated Hospital, Sun Yat-sen University, Sun Yat-Sen University Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Affiliated Hospital of Qinghai University, Zhangzhou Hospital, Fujian Province, The First Affiliated Hospital of Xiamen University, Ruijin Hospital, The First Hospital of Jilin University, Peking University Cancer Hospital & Institute, Nanchang University Second Affiliated Hospital, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, Third Affiliated Hospital, Sun Yat-Sen University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Meizhou People's Hospital
Conditions	Local Advanced Rectal Cancer, PD-1 Inhibitor, PCSK9 Inhibitor, RCT, Radiotherapy, Capecitabine, Oxaliplatin
Enrollment	148 participants
Start Date	2027-01-01
Primary Completion	2030-01-01 (estimated)
Study Completion	2035-01-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-07